FDA 510(k)

ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY

K-Number: K110913 · 2011-09-23

ApplicantEndoscopic Technologies, Inc. D/B/A Estech

Decision Date2011-09-23

Product CodeOCL

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY is the device name listed in this FDA 510(k) record. The listed applicant is Endoscopic Technologies, Inc. D/B/A Estech. It received FDA 510(k) clearance on 2011-09-23 under 510(k) number K110913. The device is classified under product code OCL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY?

ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY is a medical device that received FDA 510(k) clearance on 2011-09-23. The listed applicant is Endoscopic Technologies, Inc. D/B/A Estech. The 510(k) number is K110913.

When did ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY receive FDA 510(k) clearance?

ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY received FDA 510(k) clearance on 2011-09-23, under 510(k) number K110913.

Who is the listed applicant for ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY?

The FDA 510(k) record lists Endoscopic Technologies, Inc. D/B/A Estech as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY?

The FDA product code for ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY is OCL.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Endoscopic Technologies, Inc. D/B/A Estech as applicant

K113475ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM K100224ESTECH COBRA BIPOLSR II K091542ESTECH EASYFLOW CANNULA WITH GUIDEWIRE K091350ESTECH HAWKEYE INTRODUCER SYSTEMS

Related Devices (Code: OCL)

K252056Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)AtriCure, Inc.K234151Isolator Synergy EnCapture Ablation System (EMH)AtriCure, Inc.K221358Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surgical Ablation System (EMR2, EML2); Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide System; Isolator® Synergy Access Clamp (EMT1)AtriCure, Inc.K223508Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation DeviceMedtronic, Inc.K210477AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDEAtriCure, Inc.K211311AtriCure Isolator® Synergy™ Surgical Ablation SystemAtriCure, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.